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Bioequivalence and Pharmacokinetics Comparison of Two Formulations of Extended-Release Pentoxifylline Tablets in Healthy Subjects after Fasting and Fed Conditions
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The pharmacokinetics and bioequivalence of a newly developed extended-released (ER) tablet containing 400 mg pentoxifylline as a test product was compared with the reference brand product Trental® 400 mg ER tablet produced by Sanofi-Aventis. Two separate studies were conducted simultaneously. The first study was conducted under fasting condition, whereas, the second study was conducted under fed condition; using the same batches of the test and reference products in both studies. In each study, both products were administered to 32 healthy male adult volunteers applying a single-dose, two-treatment, two-period, two-sequence, randomized crossover design with one-week washout period between dosing. Twenty two blood samples were withdrawn from each volunteer over 24 hours period.  Pentoxifylline concentrations were determined in plasma by a validated HPLC method according to FDA Bioanalytical Method Validation Guidance using UV detection and chloramphenicol as internal standard. The lower limit of quantitation of the drug in plasma was 5 ng/ml and the upper limit of quantitation was 500 ng/ml. From the plasma concentration-time data of each individual, the pharmacokinetic parameters; Cmax,  AUC0-t, AUC0-Â¥, Cmax/AUC0-Â¥, Tmax, lZ & T0.5; were calculated applying non-compartmental analysis. Data of the test and reference products were statistically analyzed to test for bioequivalence of the two products, using criteria of FDA and EMEA Guidance.  The pharmacokinetic parameters mentioned above were statistically analyzed by descriptive statistics, ANOVA test and 90% Confidence Interval (CI). ANOVA test involved the calculation of the effects of: treatment, period, sequence and subjects nested in sequence. According to the above guidance, the primary pharmacokinetic parameters used for bioequivalence testing, namely Cmax, AUC0-t and AUC0-Â¥ were also statistically analyzed by ANOVA & CI tests using the corresponding Ln-transformed values. The mean values  Cmax,  AUC0-t , AUC0-Â¥ , Cmax/AUC0-Â¥ , Tmax, lZ & T0.5 for the test formula obtained from the fasting study  were; 144.4 ng/ml,  845.4 ng.hr/ml, 868.4 ng.hr/ml, 0.186 hr-1, 3.29 hr, 0.561 hr-1 and 1.65 hr, respectively; and the mean values of these parameters for the reference formula were; 150.0 ng/ml,  871.1 ng.hr/ml, 893.7 ng.hr/ml, 0.177 hr-1, 3.70 hr, 0.558 hr-1 and 1.59 hr,  respectively.  The mean values of the above mentioned parameters for the test formula obtained from the fed study were; 157.8 ng/ml, 826.5 ng.hr/ml, 853.8 ng.hr/ml, 0.198 hr-1, 5.4 hr, 0.458 hr-1 and 2.06 hr, respectively; and the mean values of these parameters for the reference formula were; 162.1 ng/ml, 869.7 ng.hr/ml, 894.8 ng.hr/ml, 0.196 hr-1, 4.1 hr, 0.525 hr-1 and 1.80 hr, respectively.  Based on criteria of FDA and   EMEA Guidance on Bioavailability and Bioequivalence, the results of the fasting and fed studies demonstrated bioequivalence of the two products under either condition. Accordingly, it is concluded that the newly developed ER tablet containing 400 mg pentoxifylline is bioequivalent to Trental® 400 mg ER tablet produced by Sanofi-Aventis.

Keywords: Pentoxifylline, Pharmacokinetics, Bioequivalence.

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Publication Date
Wed Aug 29 2018
Journal Name
Biomedical And Pharmacology Journal
Comparison of Some Mechanical and Physical Properties of three Types of Impression Materials with Different Dental Implant Angulations
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Choosing an appropriate impression material is a challenge for many dentists, yet an essential component to provide an excellent clinical outcome and improve productivity and profit. The purpose of present study was to compare wettability, tear strength and dimensional accuracy of three elastomeric impression materials, with the same consistencies (light-body). Three commercially available light body consistency and regular set 3M ESPE Express polyvinylsiloxane (PVS), 3M ESPE Permadyne polyether (PE), and Identium (ID), impression materials were comparedTear strength test, contact angle test and linear dimensional accuracy were evaluated for three elastic impression material. Among the three experimental groups PE impression materia

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Publication Date
Sat Oct 01 2022
Journal Name
Al–bahith Al–a'alami
ETHICAL JOURNALISM IN IRAQ AFTER 2003: Baghdad edition as a model
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The fact of having Journalism being open to people from different orientations professions, working as journalists requiring protection just to spread corruption, is one of the biggest threats faced by journalism.

Journalists noticed the spread of unprincipled journalists with no journalistic ethics amongst them, they tried to protect their profession from these corrupt outsiders who might annihilate the mighty of journalism. The principles of the journalism profession known as journalistic ethics, are one the most important formulations of the law concluded by the journalists and those concerned by the the profession, they were then published in public in order to prove their professionalism, especially for those who don’t und

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Publication Date
Wed Nov 13 2019
Journal Name
Al-kindy College Medical Journal
Early Return Of Activity Of Daily Living After Surgery Of Pfna Li Fixation In Elderly Osteoporotic Intertrochanteric
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Background:    Hip fractures are common, morbid, and costly health events that threaten independence and function of older patients . Early functional recovery is extremely important for elderly patients with femoral intertrochanteric fractures to shorten their hospital stay, omit the necessity of the further nursing and care services, and reduce associated medical expenditures . Assessment of  (ADL) is an important predictor of outcomes Of orthopedic surgery in very early postoperative period at two weeks and a month postoperatively using Japanese orthopedic score get a quick recovery of ADL & return the patient to his or her premorbid level function reducing the morbidity and mortality.

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Publication Date
Sat Dec 01 2018
Journal Name
Political Sciences Journal
Handicaps of reconstructing Iraqi strategic capabilities after 2003 (Analytical vision )
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Abstract: The issue of rebuilding the strategiccapacity of Iraq after the occupation and the US invasion in 2003 has been oneof the most contentious issues of debate and debate. It raises a number ofpolitical, social, economic, military and security problems. We say politicalprimarily because the climate and political conditions play a large and activerole along with other factors complementary to them. The important questionthat arises here is: How can the ruling political blocs move to the stage ofreconstruction without reservations? In order to answer this question, wedivided the study into three main axes. The first deals with the concept ofpower and its types. The second axis deals with the relationship betweenstrategic capa

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Publication Date
Fri Apr 01 2016
Journal Name
Journal Of Economics And Administrative Sciences
Comparing Bayes Estimators With others , for scale parameter and Reliability function of two parameters Frechet distribution
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Publication Date
Sun Dec 01 2019
Journal Name
Ieee Xplore
A Hybrid Modified Lightweight Algorithm Combined of Two Cryptography Algorithms PRESENT and Salsa20 Using Chaotic System
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Cryptography algorithms play a critical role in information technology against various attacks witnessed in the digital era. Many studies and algorithms are done to achieve security issues for information systems. The high complexity of computational operations characterizes the traditional cryptography algorithms. On the other hand, lightweight algorithms are the way to solve most of the security issues that encounter applying traditional cryptography in constrained devices. However, a symmetric cipher is widely applied for ensuring the security of data communication in constraint devices. In this study, we proposed a hybrid algorithm based on two cryptography algorithms PRESENT and Salsa20. Also, a 2D logistic map of a chaotic system is a

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Publication Date
Sun Sep 25 2022
Journal Name
American Scientific Research Journal For Engineering, Technology, And Sciences
Design and Fabrication of an Electromechanical Tester to Perform Two-dimensional Tensile Testing for Flexible Materials
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There are many diseases that affect the arteries, especially those related to their elasticity and stiffness, and they can be guessed by estimating and calculating the modulus of elasticity. Hence, the accurate calculation of the elastic modulus leads to an accurate assessment of these diseases, especially in their early stages, which can contribute to the treatment of these diseases early. Most of the calculations used the one-dimensional (1D) modulus of elasticity. From a mechanical point of view, the stresses to which the artery is subjected are not one-dimensional, but three-dimensional. Therefore, estimating at least a two-dimensional (2D) modulus of elasticity will necessarily be more accurate. To the knowledge of researchers, there i

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Publication Date
Sun Mar 02 2008
Journal Name
Baghdad Science Journal
Comparative sensitivity of two freshwater snail Melanopsis nodosa and Bulinus truncatus to 2, 4-D pesticide
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The molluscicidal effects of herbicide 2, 4-D were studied against tow species of freshwater snail Bulinus truncatus and Melanopsis nodosa by short term experiments. Calculated values of lethal concentrations (LC50 and LC100) were maid to two spices for different period of time 24hr, 48hr, 72hr and 96hr. The study had showed that the herbicide 2, 4-D was toxic against the tow species. The toxicity of the herbicide was low or unknown in low concentrations in the first period of exposure 24and 48hr to two spices but it increase gradually with increase period of exposure. The spice of B.truncatus was more tolerant than the M.nodosa. All the individual of M nodosa was death while in B.truncatus the complete death was not appear until finish the

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Publication Date
Sat Jul 01 2023
Journal Name
Electric Power Systems Research
Analytical and measurement-based wideband two-port modeling of DC-DC converters for electromagnetic transient studies
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Power-electronic converters are essential elements for the effective interconnection of renewable energy sources to the power grid, as well as to include energy storage units, vehicle charging stations, microgrids, etc. Converter models that provide an accurate representation of their wideband operation and interconnection with other active and passive grid components and systems are necessary for reliable steady state and transient analyses during normal or abnormal grid operating conditions. This paper introduces two Laplace domain-based approaches to model buck and boost DC-DC converters for electromagnetic transient studies. The first approach is an analytical one, where the converter is represented by a two-port admittance model via mo

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Publication Date
Mon Mar 08 2021
Journal Name
Journal Of Physics: Conference Series
Design and Implementation of a Moving Robot Equipped with an Arm and an FPGA to Deliver Objects between Two Positions
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Abstract<p>In this paper a system is designed and implemented using a Field Programmable Gate Array (FPGA) to move objects from a pick up location to a delivery location. This transportation of objects is done via a vehicle equipped with a robot arm and an FPGA. The path between the two locations is followed by recognizing a black line between them. The black line is sensed by Infrared sensors (IR) located on the front and on the back of the vehicle. The Robot was successfully implemented by programming the Field Programmable Gate Array with the designed system that was described as a state diagram and the robot operated properly.</p>
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